Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cediranib · 11 trials · 14 indications
For patients with measurable disease at entry (at least one lesion that has a shortest diameter ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that: 1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days. 2. The patient has died from any cause. 3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
Number of months from randomisation to the date of death from any cause
The number of patients free of grade III-V gastrointestinal perforation or fistula during cediranib treatment. This is causally related to cediranib or the cediranib olaparib combination, during cediranib treatment until patient withdraws, dies or has been treated with cediranib for at least 18 weeks, and for 28 days following the last dose. The proportion will be calculated with an exact 95% confidence interval (CI) calculated using the Clopper-Pearson method.
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Area under plasma concentration-time curve from zero to infinity
Maximum plasma drug concentration
| Arm | Type | Description |
|---|---|---|
| Cediranib 30mg | EXPERIMENTAL | Cediranib 30mg |
| Cediranib 20mg + lomustine | OTHER | Cediranib 20mg + lomustine |
| Lomustine and Placebo Cediranib | ACTIVE_COMPARATOR | Lomustine and Placebo Cediranib |
| FOLFOX + placebo Cediranib | PLACEBO_COMPARATOR | FOLFOX + placebo Cediranib |
| Xelox + placebo Cediranib | PLACEBO_COMPARATOR | Xelox + placebo Cediranib |
| FOLFOX + Cediranib | EXPERIMENTAL | FOLFOX + Cediranib |
| XELOX + Cediranib | EXPERIMENTAL | XELOX + Cediranib |
| Cediranib | EXPERIMENTAL | Cediranib 20mg/day with weekly paclitaxel 70mg/m2/week. At the point of developing progressive disease (PD), patients will have the option of ceasing paclitaxel and continuing cediranib 20mg/day with olaparib 300mg bd continuously until further PD occurs. |
| 1 | PLACEBO_COMPARATOR | Cediranib placebo |
| 2 | EXPERIMENTAL | Cediranib |
| Cediranib 45 mg Fed | EXPERIMENTAL | Part A: Cediranib 45 mg Fed State |
| Cediranib 45 mg Fasted | EXPERIMENTAL | Part A: Cediranib 45 mg Fasted State |
| Cediranib 45 mg Fixed Dose | EXPERIMENTAL | Part B: Cediranib 45 mg Fixed Dose |
| Cediranib 30 - 90 mg Dose Escalation | EXPERIMENTAL | Part B: Cediranib 30 - 90 mg Dose Escalation |
| Treatment A | OTHER | Cediranib 20mg + Cisplatin + S-1 |
| Treatment B | OTHER | Cediranib 20mg + Cisplatin + Capecitabine |
| Name | Type | Description |
|---|---|---|
| Cediranib | DRUG | 30 mg/day, oral, until progression |
| Lomustine Chemotherapy | DRUG | 110 mg/m2 / Q6W, oral, until progression |
| Placebo Cediranib | DRUG | Oral, until progression |
| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) | DRUG | intravenous infusion |
| XELOX (Capecitabine and Oxaliplatin) | DRUG | intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15) |
| Cediranib Placebo | DRUG | oral tablet |
| Bevacizumab | DRUG | intravenous infusion |
| 5-fluorouracil ( in FOLFOX) | DRUG | intravenous infusion |
| Leucovorin (in FOLFOX) | DRUG | intravenous infusion |
| Oxaliplatin (in FOLFOX) | DRUG | intravenous infusion |
| Cediranib 30 - 90 mg | DRUG | oral tablet dose escalation |
| cediranib (RECENTIN TM, AZD2171) | DRUG | 20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8 |
| Cisplatin | DRUG | Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given. |
| S-1 | DRUG | Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. |
| Capecitabine | DRUG | Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. |
| Lomustine | DRUG | oral capsule |
Inclusion Criteria: * Confirmation of recurrent glioblastoma * Life expectancy ≥ 12 weeks * Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide Exclusion Criteria: * Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation...
Cediranib is an investigational small molecule being studied for advanced solid malignancies, bowel obstruction, metastatic colorectal cancer, cancer, gastric cancer, and renal cell carcinoma. It is in Phase 2 clinical development and is not approved by the FDA.
Cediranib is a kinase inhibitor that targets FLT1, FLT4, KDR, PDGFRB, PDGFRA, and KIT. These are receptor tyrosine kinases involved in tumor growth and angiogenesis.
Cediranib is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Cediranib is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials include Phase 1 and Phase 3 studies that have been completed.
Cediranib has been studied in trials including NCT00503204, a Phase 1 study in recurrent glioblastoma; NCT00777153, a Phase 3 study in recurrent glioblastoma; NCT00960349, a Phase 1 study in gastric cancer; and NCT00981721, a Phase 1 pharmacokinetic study in advanced solid malignancies.
Cediranib is also known as AZD2171, a name used in earlier research. It is a small molecule tyrosine kinase inhibitor developed by AstraZeneca for oncology indications.